Vitd and Barrier Function in IBD

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT01792388
• Date of registration: 19/12/2012
• Prospective Registration: No
• Primary sponsor: University of Dublin, Trinity College
• Public title: Vitd and Barrier Function in IBD VIP
• Scientific title: Vitamin D and Its Effects on Inflammation and Intestinal Permeability in Crohn's Disease in Remission
• Date of first enrolment: December 2011
• Target sample size: 30
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT01792388
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
• Phase: Phase 4

Countries of recruitment

Ireland

Contacts

• Name: Maria O'Sullivan, PhD
• Affiliation: Trinity College Dublin

Key inclusion & exclusion criteria

Inclusion Criteria:

- All patients must fulfill the clinical criteria for diagnosis of CD as defined by
Lennard-Jones et al. (1976)

- All patients must be in clinical remission for at least 1 month at study entry as
defined by a Crohn's Disease Activity Index (CDAI) of <150

- 18-65 years

- Patients on stable drug therapies for at least 1 month pre-enrolment

- Sufficient English language ability to carry out the study requirements

Exclusion Criteria:

- Symptomatic CD at study entry including CDAI >150

- Pregnancy

- Previous extensive small bowel resection (less than 200 cm of viable small bowel or a
loss of 50% or more of the small intestine)

- Presence of an ileostomy or colostomy

- Known hypersensitivity to vitamin D

- Hypercalcaemia (corrected serum calcium > 2.66 mmol/L)

- Those currently using supplemental vitamin D >800 IU/D

- Diagnosis of any of the following: active tuberculosis, sarcoidosis,
hyperparathyroidism, renal failure, pseudohyperparathyroidism, malignancy, active,
lymphoma, short bowel syndrome

- Antibiotic use in the 4 weeks prior to enrolment

- Current use of bisphosphonates

- Renal Impairment, Diabetes Mellitus

- Patients participating in a concurrent RCT

- Alcohol dependency



Age minimum: 18 Years
Age maximum: 70 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Crohn's Disease

Intervention(s)

Dietary Supplement: Soya Bean oil

Dietary Supplement: Vitamin D

Primary Outcome(s)

Change from Baseline Intestinal Permability from baseline and 3 months [Time Frame: 0 and 3 months]

Secondary Outcome(s)

Change in Inflammatory and antimicrobial peptide levels from baseline to 3 months [Time Frame: Baseline and 3months]

To assess change in grip strength and associated fatigue markers [Time Frame: Baseline and 3 months]

Secondary ID(s)

vip

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Queen Mary University of London

University of Calgary